MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE AUTOGUARD BC; INTERVASCULAR CATHETER

Catalog Number 381023

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/12/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a catheter tip of bd¿ insyte autoguard bc was damaged before use.

Manufacturer Narrative

Additional information: b.5.Describe event or problem: it was reported that a catheter tip of bd¿ insyte autoguard bc was damaged before use.Foreign matter was also found on the catheter tip upon investigation.H.6.Invesigation summary: dhr disclosed the following: lot 7334848: lot was built and packaged on afa line 11 from 06dec2017 through 08dec2017 for the quantity of 343,210ea.There were no indications of the defect as there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.All required challenges samples and testing was conducted per specification in accordance with the setup and in-process sampling plans during the build of the product.In process samples for foreign/non-foreign material, and particulate loose or embedded were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.Unit: received one 22ga bd insyte autoguard bciv catheter unit within an undamaged opened package from lot 7334856.All components were present with the needle/hub assembly fully retracted within the safety shield (barrel).Photos: two photos were provided for evaluation of this incident photo revealed the unit to be in similar condition as that of the returned sample.Photo revealed the tip of the catheter tubing which shown to have a white fm present.Visual/microscopic evaluation: unit: visual observation revealed there was white fm present near the tip of the catheter tubing.Microscopic evaluation confirmed the fm was identified to be non-foreign (porous plug shaving residual) which was introduced during the manufacturing process.No other damage was observed.Photos: the non-foreign (porous plug shaving residual) seen on the returned unit was also seen in the provided photo.Confirmation of the defect of foreign matter, was conclusive based on the observations of the unit and photos provided for this incident.Conclusion(s): relationship of device to the reported incident: manufacturing - the characteristics of the fm (non-foreign / porous plug residual); was evidence to confirm and support manufacturing process related issues for the reported defect; as the non-foreign was introduced during the manufacturing process.

Event Description

It was reported that a catheter tip of bd¿ insyte autoguard bc was damaged before use.Foreign matter was also found on the catheter tip upon investigation.

• Brand Name: BD¿ INSYTE AUTOGUARD BC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8204221
• MDR Text Key: 131704715
• Report Number: 1710034-2018-00946
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2020
• Device Catalogue Number: 381023
• Device Lot Number: 7334856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Manufacturer Received: 12/12/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/12/2018
• Supplement Dates FDA Received: 02/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other